FDA 483 - Caltag Medsystems Ltd - May 04, 2023

An FDA Form 483 was issued to Caltag Medsystems Ltd, a medical device manufacturer in Buckingham, UK, following an inspection conducted from May 2 to May 4, 2023. The inspection highlighted several deviations from regulatory requirements related to the company's quality management system. Key observations included deficiencies in design review processes and a lack of established or maintained procedures for design transfer, specifically noting an absent design transfer record for TransFix Vacuum Blood Collection Tubes to a contract manufacturer. Additionally, the inspection found that certain processes, whose results cannot be fully verified by subsequent inspection and testing, were not adequately validated according to established procedures. Issues with labeling were also noted, alongside inadequate documentation of corrective and preventive action (CAPA) activities, including the lack of proper effectiveness checks and review processes from a previous FDA audit. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, underscore areas where the firm's practices require improvement to ensure compliance. Caltag Medsystems Ltd has committed to addressing each observation by implementing corrective actions, and is expected to conduct thorough internal self-audits to resolve all identified issues.